Panadol 500mg Tablets

Country: Malta

Language: English

Source: Medicines Authority

Active ingredient:

paracetamol 500 mg

Available from:

GlaxoSmithKline Consumer Healthcare (Ireland) Limited

ATC code:

N02BE01

INN (International Name):

paracetamol

Pharmaceutical form:

film-coated tablet

Authorization status:

Authorised

Authorization date:

2006-04-18

Patient Information leaflet

484
500MG
FILM-COATED TABLETS 
PARACETAMOL
PATIENT INFORMATION LEAFLET
PLEASE READ RIGHT THROUGH THIS LEAFLET  
BEFORE YOU START USING THIS MEDICINE.
This medicine is available without  
prescription, but you still need to use  
Panadol tablets carefully to get the best  
results from them.
•   Keep this leaflet, you may need to read 
it again. 
•  If you have any further questions, ask  
your pharmacist.
IN THIS LEAFLET:
1.  What Panadol tablets are and what they 
are used for
2.  Check before you take Panadol tablets
3.  How to take Panadol tablets
4.  Possible side effects
5.  How to store and dispose of Panadol 
tablets 
6.  Further information
1.  WHAT PANADOL TABLETS ARE AND 
WHAT THEY ARE USED FOR
PANADOL TABLETS ARE USED FOR FAST AND 
EFFECTIVE RELIEF OF HEADACHES, TOOTHACHE, 
BACKACHE, RHEUMATIC AND MUSCLE PAINS 
AND PERIOD PAIN. It also relieves sore throat 
and the feverishness, aches and pains of  
colds and flu. Panadol tablets also provide 
relief from the pain associated with 
osteoarthritis as diagnosed by a doctor.
The active ingredient is paracetamol which  
is a painkiller and also reduces your 
temperature when you have a fever. 
2.  CHECK BEFORE YOU TAKE PANADOL 
TABLETS
DO NOT TAKE PANADOL TABLETS:
•  IF YOU HAVE EVER HAD AN ALLERGIC 
REACTION to paracetamol or to any of the 
other ingredients (listed in Section 6).
•  if you are TAKING OTHER MEDICINES 
CONTAINING PARACETAMOL.
•  if you are UNDER 6 YEARS unless your 
doctor tells you to.
ASK YOUR DOCTOR BEFORE YOU TAKE 
THIS MEDICINE:
•  if you have SEVERE LIVER or KIDNEY 
DISEASE, including ALCOHOLIC LIVER 
DISEASE.
IF YOU ARE TAKING OTHER 
MEDICINES
Talk to your doctor or pharmacist before  
taking these tablets if you are taking any 
prescribed medicines; particularly 
METOCLOPRAMIDE or DOMPERIDONE (for 
NAUSEA [feeling sick] or VOMITING [being  
sick]); COLESTYRAMINE (to lower BLOOD  
CHOLESTEROL). If you take BLOOD THINNING  
DRUGS (ANTICO

Summary of Product characteristics

Page 1 of 5

SUMMARY OF PRODUCT CHARACTERISTICS 

1. 
NAME OF THE MEDICINAL PRODUCT 

Panadol 500mg Film-coated tablets 

2. 
QUALITATIVE AND QUANTITATIVE COMPOSITION 

Each tablet contains Paracetamol 500mg. 

For a full list of excipients see section 6.1 

3. 
PHARMACEUTICAL FORM 

Film coated tablet. 
White capsule shaped film coated tablet with a triangular logo
embossed on one face and 
scored with a breakline on the other face. 

4.  
CLINICAL PARTICULARS 

4.1. 
THERAPEUTIC INDICATIONS 

Panadol is a mild analgesic and antipyretic.  The tablets
are recommended for use in the short-
term management of headaches, musculoskeletal disorders, menstrual
pains, toothache and for 
symptoms of common colds and flu. Panadol may also be used in the symptomatic relief of 
mild to moderate pain associated with osteoarthritis as diagnosed
by a doctor. 

4.2. 
POSOLOGY AND METHOD OF ADMINISTRATION 

Panadol is for oral administration. 

Adults (including the elderly) 

2  tablets  repeated  if  necessary  3-  4  times  a  day  to  a  maximum  of  8  tablets  in  any  24  hour 
period. 

Children 6-12 years:  

½ - 1 tablet repeated if necessary 3- 4 times a day to a maximum of 4 tablets in any 24 hour 
period. 

Panadol tablets are not suitable for children under 6 years
of age. 

These doses should not be repeated more frequently than every 4 hours and not more than 4 
doses should be given in any 24 hour period. 

Maximum duration of continued use without medical advice: 3 days. 

Page 2 of 5

4.3. 
CONTRAINDICATIONS 

Hypersensitivity to paracetamol or any of the other constituents. 

Use in children under 6 years of age. 

4.4. 
SPECIAL WARNINGS AND PRECAUTIONS FOR USE 

Caution is advised in the administration of paracetamol t